Ra Process
6 months ago
Johnson & Johnson is recruiting for a RA Process & Compliance Officer NEMA, to belocated in Cairo, Egypt.
**Key Responsibilities**:
**Manage the Regulatory Affairs **Process **& **Compliance activities**:
- Keep oversight, reporting and support for Labeling management and systems.
- Assess and manage development of new business support processes and capabilities to meet the needs of the evolving Business and Regulatory environment.
- Design, implement and assess, as needed, systems and tools to support the MA-FSA Regulatory team’s activity.
- Identify, set and monitor individual objectives and the means of implementation.
- Radiate positive compliance driven environment and business continuity.
- Organize and facilitate collaboration
**Manage Quality and Operational **processes linked to RA **activities**:
- Develop, deploy and optimize processes vertically between Global/EMEA, Regional office and countries and horizontally to ensure alignment within NEMA cluster (e.g. work closely with Near East Compliance professional)
- Ensure efficient implementation and maintenance of the key RA processes and corresponding systems, including but not limited to: Change controls, local deviations, CAPAs and escalations; Document management, knowledge management, records management and archiving; onboarding process and training ; Regulatory Intelligence
- Provide regulatory process support for Regulatory Experts and professionals to ensure they recognize procedures they should adhere to.
**Support RA compliance in the region**:
- Establish and maintain Compliance oversight in the region through appropriate tools (e.g. dashboards and trend analyses of compliance data from GRA systems)
- Produce Monthly Metrics on labelling, CMC variations and renewals being processed. Identify any backlog variations or renewals and work with RA to ensure appropriate actions are being taken to manage the backlog including opening of Quality Issues where necessary.
- Subject Matter Expert for implementation and compliance of GRA Systems
- Coordinate the RA preparation, input, support and follow-up of inspections, audits and compliance related processes.
- Main interface/contact point for all Systems and RIM discussions involving or impacting the region
- Guide RA Experts and Professionals on maintaining compliance for internal systems.
**Qualifications**:
**Qualifications**:
**Experience and Skills**:
- Minimally degree in Pharmacy.
- 4 years’ experience in Regulatory Affairs within a multinational organization, preferably regulatory compliance experience
- Having a professional working proficiency in French is a plus
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
- Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
-
Ra Compliance Lead Gcc and Nema
7 months ago
مصر, Egypt Johnson & Johnson Full timeJohnson & Johnson is recruiting for a RA Compliance Lead GCC and NEMA, Egypt. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson &...
-
Regulatory Affairs Process
7 months ago
مصر, Egypt Johnson & Johnson Full time**Position Summary**: In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping...
-
Regulatory Labeling
6 months ago
مصر, Egypt Johnson & Johnson Full timeJohnson & Johnson is recruiting for a Regulatory Labeling & Compliance Specialist, located in Cairo, Egypt. **Key Responsibilities**: - Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission and implementation, follow up on approvals and implementation...
-
Ermc Translation Management Associate
7 months ago
مصر, Egypt Johnson & Johnson Full time**About Johnson & Johnson**: Johnson & Johnson is recruiting for an EMEA RMC Translation Management Associate in Egypt. The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs (RA) team responsible for operational regulatory activities, acting on behalf of Local Operating Companies (LOCs). This virtual team is embedded in the EMEA RA...
-
Regulatory Affairs and Quality Associate Cw
8 months ago
مصر, Egypt Zoetis Full time**Position Summary**: - Support in Regulatory Affairs and Quality operations in the affiliate, in collaboration with the affiliate RA Manager and Quality Lead; including maintaining an appropriate Quality Management System. - Provide Regulatory Affairs and Quality Operations support to the local affiliate to help the market(s) achieve their revenue and...
-
Cloud Security Operations Engineer
6 months ago
مصر, Egypt Orange Business Full time**About the role**: Key tasks and responsibilities: - Troubleshooting and resolving high complexity customer faults. - Provide next level technical support for Level 1 Specialists. - When resolution is not possible ensuring the fault is passed to the most appropriate group able to resolve. - Perform service changes by assessing risk and implementing...
-
Dispatcher - Ras Ghareb, Egypt
7 months ago
مصر, Egypt Vestas Full timeAt Vestas, we live our company values of Accountability, Collaboration, Simplicity and Passion. In an innovative and evolving industry, we change quickly to meet the needs of our customers. Our motivation is to preserve the environment through sustainable energy solutions. If this aligns with your values and enthusiasm, we want to hear from...
-
Marketing Senior Manager
7 months ago
مصر, Egypt Savola Full time**Supervision of Subordinates**:Organize and supervise the activities and work of a small team of subordinates to ensure that all work within a specific area of OU-Marketing activity is carried out in an efficient and procedurally compliant manner - **Budgets and Plans**:Contribute to the preparation of the OU-Marketing section budget and monitor financial...
-
Network Security Engineer
7 months ago
مصر, Egypt Orange Full timeSupport and Operate Security Services and offers provided to a vast number of Customers worldwide to secure high quality levels and almost 100% service availability. - Act as Second level of support and deliver different security services management aspects: incident, change, release, capacity, and vulnerability management. - Resolve service incidents by...
-
Purchasing & Supply Chain & Regulatory Affairs
6 months ago
مصر, Egypt DSM-Firmenich Full time.. Within our Animal Nutrition & Health buiness, we are currently looking for Purchasing & Supply Chain & RA Specialist for our new production site at Sadat City, Egypt. You will report directly to the Head of Operating Unit Commercial Operations. At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities...
-
Safety Assurance Engineer
6 months ago
مصر, Egypt ALSTOM Full timeReq ID:454385 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues lead the way to greener and smarter...
-
Railway Safety Assurance Engineer
7 months ago
مصر, Egypt ALSTOM Full timeReq ID:454385 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues lead the way to greener and smarter...
-
Customer Service Manager
6 months ago
مصر, Egypt Acino Full timeAcino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and empathy and provide an environment that supports...
-
Regulatory Affairs Specialist
6 months ago
مصر, Egypt Takeda Pharmaceutical Full time**_ OBJECTIVES:_** - Responsible for directing all day to day regulatory affairs activities in the assigned countries within Oman, Bahrain & Qatar countries to ensure compliance with all regulations. - Implements regulatory strategies for the earliest possible product approvals and ensures the timely creation, preparation, and achievement of organized valid...